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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
NCT ID:
NCT03107793
Description:
For Induction period: The safety analysis set included all participants from the full analysis set (FAS). For Maintenance period: Full randomized analysis set (FRAS) included all participants who received at least 1 dose of study agent and were randomized at Week 16, regardless of study treatment being administered once randomized. For Extension period: Modified FAS (mFAS) included all participants randomized at Week 16 that completed Week 48 and entered the extension period.
Frequency Threshold:
2
Time Frame:
Induction Period= Baseline up to Week 16; Maintenance Period= Baseline up to Week 48; Extension Period/End of Study= Baseline up to Week 104. In maintenance period and extension period AEs are reported that occurred between baseline and Week 48 and between baseline and Week 104, respectively, i.e., there is an overlap.
Study:
NCT03107793
Study Brief:
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Induction Period | Participants were administered with approximately 6 mg/kg intravenous (IV) injection of ustekinumab at Week 0 and 90 mg subcutaneous (SC) injection of ustekinumab at Week 8. At Week 16, participants who did not achieve a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (\>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either with treat to target arm or routine care arm. | 0 | None | 28 | 498 | 238 | 498 | View |
| Maintenance Period: Treat to Target | Participants with less than (\<) 25 percent (%) improvement in simple endoscopic score for Crohn's disease (SES-CD) at Week 16 versus baseline received ustekinumab 90 mg SC dose 8-weekly maintenance treatment while participants with \>= 25% improvement in SES-CD score at Week 16 versus baseline received ustekinumab 90 mg SC dose 12-weekly treatment based on centrally-read ileocolonoscopy findings. From Week 24, participants assigned to the 8-weekly regimen or from Week 20 for the 12-weekly regimen group ustekinumab 90 mg SC maintenance treatment was directed by treat to target assessments based on C-reactive protein (CRP) and CDAI assessments. Participants previously on 12-weekly regimens were adjusted to 8-weekly dosing; those previously on 8-weekly regimens were adjusted to 4-weekly dosing. Participants subsequently failing to meet treatment targets at the next assessment visit 4 weeks after dosing were not able to optimize dosing further and left the study. | 2 | None | 26 | 219 | 158 | 219 | View |
| Maintenance Period: Routine Care | Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment. | 0 | None | 29 | 221 | 150 | 221 | View |
| Extension Period: Treat to Target | From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 milligrams per liter \[mg/L\] and fecal calprotectin \<=250 micrograms per gram \[mcg/g\]) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued. | 0 | None | 21 | 147 | 125 | 147 | View |
| Extension Period: Routine Care | From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 mg/L and fecal calprotectin \<=250 mcg/g) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued. | 1 | None | 23 | 176 | 135 | 176 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 24.0 | View |
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| Cardiac Failure Acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 24.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Anal Fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Crohn's Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Fistula of Small Intestine | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Intestinal Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Intestinal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Intra-Abdominal Fluid Collection | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Large Intestine Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Large Intestine Polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Pancreatitis Acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Subileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Cardiac Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Abdominal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Abdominal Wall Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Abscess Intestinal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Anal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Bartholinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Campylobacter Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Covid-19 Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Enteritis Infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Infectious Colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Large Intestine Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Perirectal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Head Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Joint Dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Body Temperature Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Osteitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Cervix Neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| Invasive Ductal Breast Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| Lung Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| Malignant Melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| Neuroendocrine Carcinoma Metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| Plasma Cell Myeloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| Superficial Spreading Melanoma Stage Unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Dizziness Exertional | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Temporal Lobe Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Major Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| Suicide Attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 24.0 | View |
| Ureterolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 24.0 | View |
| Female Genital Tract Fistula | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.0 | View |
| Metrorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.0 | View |
| Chronic Obstructive Pulmonary Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 24.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 24.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.0 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 24.0 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Anal Fissure | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Anal Fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Crohn's Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Frequent Bowel Movements | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Anal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Gastrointestinal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Oral Herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Tooth Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Vaginal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Ligament Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| C-Reactive Protein Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| Serum Ferritin Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| Folate Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| Iron Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| Vitamin B12 Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| Vitamin D Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 24.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 24.0 | View |
| Renal Colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 24.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Productive Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Skin Lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |