Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2025-12-25 @ 12:04 PM
NCT ID:
NCT01920061
Description:
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
Frequency Threshold:
5
Time Frame:
Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Study:
NCT01920061
Study Brief:
A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 1: 1L Metastatic | Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days. | 0 | None | 2 | 10 | 10 | 10 | View |
| Arm B4: 150 mg PF-05212384 + Cisplatin | Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 0 | None | 3 | 3 | 3 | 3 | View |
| Arm 2: 2L/3L Metastatic | Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days. | 1 | None | 4 | 12 | 12 | 12 | View |
| Arm B5: 180 mg PF-05212384 + Cisplatin | Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 1 | None | 3 | 3 | 3 | 3 | View |
| Arm B6: 215 mg PF-05212384 + Cisplatin | Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 0 | None | 4 | 10 | 10 | 10 | View |
| Arm B7: 260 mg PF-05212384 + Cisplatin | Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 1 | None | 2 | 5 | 5 | 5 | View |
| Arm B8: 310 mg PF-05212384 + Cisplatin | Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 0 | None | 2 | 2 | 2 | 2 | View |
| Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib | Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days. | 0 | None | 3 | 15 | 15 | 15 | View |
| Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib | Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days. | 2 | None | 2 | 4 | 4 | 4 | View |
| Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib | Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days. | 0 | None | 3 | 7 | 7 | 7 | View |
| Arm A3: 130 mg PF-05212384 + Docetaxel | Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days. | 0 | None | 0 | 3 | 3 | 3 | View |
| Arm A4: 150 mg PF-05212384 + Docetaxel | Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days. | 1 | None | 1 | 3 | 3 | 3 | View |
| Arm A5: 180 mg PF-05212384 + Docetaxel | Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days. | 0 | None | 1 | 5 | 5 | 5 | View |
| Arm B1: 90 mg PF-05212384 + Cisplatin | Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 0 | None | 1 | 4 | 4 | 4 | View |
| Arm B2: 110 mg PF-05212384 + Cisplatin | Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 0 | None | 1 | 3 | 3 | 3 | View |
| Arm B3: 130 mg PF-05212384 + Cisplatin | Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days. | 1 | None | 1 | 3 | 3 | 3 | View |
| Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib | Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days. | 0 | None | 0 | 3 | 3 | 3 | View |
| Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib | Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days. | 0 | None | 0 | 3 | 3 | 3 | View |
| Arm A1: 90 mg PF-05212384 + Docetaxel | Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days. | 1 | None | 2 | 4 | 4 | 4 | View |
| Arm A2: 110 mg PF-05212384 + Docetaxel | Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days. | 1 | None | 2 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Infectious mononucleosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Pneumonia influenzal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Dermatitis exfoliative generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Vascular device infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nail bed infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Vascular device infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Skin abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Wound dehiscence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Blood creatine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood magnesium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood phosphorus decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Platelet count | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Staphylococcus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Hyperphosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypochloraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Spinal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Speech disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Tumour pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Dysaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Dystonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Extrapyramidal disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Panic attack | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Vulvovaginal inflammation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Vulvovaginal pruritus | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Laryngeal inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Nasal dryness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Pleuritic pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Dermatitis exfoliative generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Dermatomyositis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Nail dystrophy | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Prurigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Skin lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Systemic lupus erythematosus rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Iron deficiency anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Thrombocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Motion sickness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Chalazion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Dry eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Extraocular muscle paresis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Swelling of eyelid | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Visual acuity reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 22.1 | View |
| Anal pruritus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Faeces discoloured | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Faeces soft | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Salivary hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Cheilosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Lip pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Oesophageal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Paraesthesia oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Regurgitation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Aphthous ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Gingival bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Hypoaesthesia oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Oral mucosal blistering | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Oral mucosal erythema | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Tongue dry | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Feeling cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Catheter site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Early satiety | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Facial pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Infusion site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Puncture site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Secretion discharge | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Axillary pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Catheter site irritation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Hepatic pain | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Hepatomegaly | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 22.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Ecthyma | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Eyelid folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Infected cyst | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Vulvitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Vulvovaginal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Candida infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Localised infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Tooth abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 22.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood calcium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Creatinine renal clearance abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Glycosylated haemoglobin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Grip strength decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Human epidermal growth factor receptor decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Fluid overload | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Fluid retention | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Groin pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Limb discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Synovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Plantar fasciitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Drooling | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Visual field defect | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Mental disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Cystitis haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Micturition disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Glycosuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Renal disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Aphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Nasal discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Oropharyngeal discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Paranasal sinus hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Throat irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Catarrh | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Upper respiratory tract congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Nail discolouration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Onychoclasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Onycholysis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Onychomadesis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Scab | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Skin toxicity | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Intertrigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Onychalgia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Skin fissures | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Skin mass | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Umbilical discharge | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Ingrowing nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Macule | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Nail disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Nail ridging | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Photosensitivity reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Hypovolaemic shock | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Thrombophlebitis superficial | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Metastases to meninges | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Cancer pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Oedema genital | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Vaginal discharge | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Vulvovaginal dryness | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Breast pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22.1 | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 22.1 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 22.1 | View |
| Infusion site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypertrichosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
| Lymphocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Deafness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Deafness neurosensory | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Ototoxicity | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 22.1 | View |
| Blindness | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Ocular hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Photopsia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Gingival recession | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Glossodynia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Impaired gastric emptying | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Lip disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Odynophagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Oral disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Oral dysaesthesia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Periodontal disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Proctitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Catheter site dermatitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Catheter site rash | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Infusion site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Lymphangitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Taste disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Nasal inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Dermatitis acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |