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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
NCT ID:
NCT01998958
Description:
Safety analysis set for double-blind and open-label phase included all randomized participants who receive at least 1 dose of study drug in the respective phases. For follow-up phase safety population included all participants who entered in follow up phase.
Frequency Threshold:
0
Time Frame:
Up to 21 weeks
Study:
NCT01998958
Study Brief:
A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo to Esketamine 56mg (Panel A and B: Period 2) | Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B. | None | None | 0 | 12 | 11 | 12 | View |
| Placebo to Esketamine 84 mg (Panel A: Period 2) | Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. | None | None | 0 | 5 | 5 | 5 | View |
| Placebo (Panel A and Panel B: Period 2) | All participants who received placebo in Period 2 of Panel A and B (including participants with QIDS-SR16 score \>=11 and QIDS-SR16 score \<11) in double-blind phase. | None | None | 1 | 23 | 12 | 23 | View |
| Esketamine 14 mg (Panel B: Period 2) | Participants who received esketamine 14 mg in Period 1 of Panel B continued to receive esketamine 14 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2 of Panel B. | None | None | 0 | 16 | 11 | 16 | View |
| Esketamine 56 mg (Panel A and B: Period 2) | Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly re-assigned to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 of Period 2. Panel B: Participants who were responders (with QIDS-SR16 score \<11) at the end of Period 1 in Panel B continued to receive esketamine 56 mg (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 8 and 11 in Period 2. | None | None | 0 | 32 | 26 | 32 | View |
| Placebo/Placebo/Open Label Esketamine (Panel A and B) | Panel A: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with open label (OL) phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32, 39, 46,60,74. Doses for optional OL phase included 28, 56, and 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39,46 could be adjusted to next lower or higher dose, based on investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60, 74. Panel B: Participants who received Placebo in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to next lower or higher dose, based on investigator's clinical judgment. | None | None | 0 | 23 | 23 | 23 | View |
| Placebo/Esketamine/Open Label Esketamine (Panel A and B) | Panel A: Participants who received Placebo in Period 1, esketamine in Period 2 and elected to continue with OL phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60, 74. Doses for OL phase included 28,56,84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74. Panel B: Participants who received Placebo in Period 1 and esketamine in Period 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15,18,22,25. Doses for OL phase included 14,28,56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18,22,25 could be adjusted to next lower or higher dose, based on the investigator's clinical judgment. | None | None | 0 | 27 | 22 | 27 | View |
| Esketamine/Esketamine/Open Label Esketamine (Panel A and B) | Panel A: Participants who received esketamine in Period 1 and 2 and elected to continue with open label phase received up to 9 single doses of intranasal esketamine on Days 15,18,22,25,32,39,46,60,74. Doses for OL treatment phase included 28, 56, 84 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22,25,32,39, 46 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. Same dose administered on Day 46 was administered on Day 60,74.Panel B: Participants who received esketamine in Period 1 and 2 of Panel A and elected to continue with OL phase received up to 4 single doses of intranasal esketamine on Days 15, 18, 22, 25. Doses for OL phase included 14, 28, 56 mg of esketamine. All participants started with intranasal esketamine 56 mg on Day 15. Subsequent doses on Days 18, 22, 25 could be adjusted to the next lower or higher dose, based on the investigator's clinical judgment. | None | None | 1 | 46 | 39 | 46 | View |
| Esketamine 14 mg: Follow up Phase | All participants whose last dose was esketamine 14 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks. | None | None | 0 | 4 | 1 | 4 | View |
| Esketamine 28 mg: Follow up Phase | All participants whose last dose was esketamine 28 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks. | None | None | 1 | 12 | 4 | 12 | View |
| Esketamine 28 mg (Panel A: Period 2) | Participants who received esketamine 28 mg in Period 1 of Panel A continued to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. | None | None | 0 | 16 | 8 | 16 | View |
| Placebo: Follow up Phase | All participants whose last dose was Placebo in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks. | None | None | 0 | 1 | 0 | 1 | View |
| Esketamine 56 mg: Follow up Phase | All participants whose last dose was esketamine 56 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks. | None | None | 1 | 39 | 10 | 39 | View |
| Esketamine 84 mg: Follow up Phase | All participants whose last dose was esketamine 84 mg in the double-blind phase or open label phase and were not consent withdrawn were followed for safety for 8 weeks. | None | None | 1 | 42 | 7 | 42 | View |
| Esketamine 14 mg (Panel B: Period 1) | Participants self administered esketamine 14 mg intranasally (1 spray of esketamine 14 mg into one nostril and 1 spray of placebo into other nostril at 0 minute and then 1 spray of placebo to each nostril at 5 minutes) on Days 1 and 4 of Period 1 in Panel B. | None | None | 0 | 11 | 6 | 11 | View |
| Esketamine 56 mg (Panel A and B: Period 1) | Panel A: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0 and 5 minute and 1 spray of placebo to each nostril at 10 minutes) on Days 1 and 4 of Period 1. Panel B: Participants self administered esketamine 56 mg intranasally (1 spray of esketamine 14 mg into each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1. | None | None | 0 | 20 | 18 | 20 | View |
| Esketamine 84 mg (Panel A: Period 1) | Participants self administered esketamine 84 mg intranasally (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A. | None | None | 0 | 12 | 10 | 12 | View |
| Esketamine 84 mg (Panel A: Period 2) | Participants who received esketamine 84 mg in Period 1 of Panel A continued to receive esketamine 84 mg (1 spray of esketamine 14 mg to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. | None | None | 0 | 17 | 12 | 17 | View |
| Placebo (Panel A and B: Period 1) | Panel A: Participants self-administered placebo intranasally (1 spray to each nostril at 0, 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A. Panel B: Participants self-administered placebo intranasally (1 spray to each nostril at 0 and 5 minutes) on Days 1 and 4 of Period 1 in Panel B. | None | None | 0 | 54 | 27 | 54 | View |
| Esketamine 28 mg (Panel A: Period 1) | Participants self administered esketamine 28 milligram (mg) intranasally (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 1 and 4 of Period 1 in Panel A. | None | None | 0 | 11 | 8 | 11 | View |
| Placebo (Panel A and B: Period 2) QIDS >=11 Participants | Panel A: Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive same Placebo (1 spray to each nostril at 0, 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. Panel B: Participants who were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were randomly assigned to receive placebo intranasally (1 spray of placebo into each nostril at 0 and 5 minutes using 4 separate devices) on Days 8 and 11 of Period 2 in Panel B. | None | None | 1 | 23 | 15 | 23 | View |
| Placebo to Esketamine 14mg (Panel B: Period 2) | Participants who received placebo in Period 1 and were non-responders with QIDS-SR16 score \>=11 at the end of Period 1 were randomly reassigned to receive esketamine 14 mg intranasally (1 spray of esketamine 14 mg into once nostril and 1 spray of placebo in other nostril at 0 minute and 1 spray of placebo in each nostril at 5 minutes using 4 separate devices) on Days 8 and 11 in Period 2 of Panel B. | None | None | 0 | 5 | 5 | 5 | View |
| Placebo to Esketamine 28mg (Panel A: Period 2) | Participants who were non-responders at the end of Period 1 in Panel A (with QIDS-SR16 score \>=11) were randomly reassigned to receive esketamine 28 mg (1 spray of esketamine 14 mg to each nostril at 0 minute and 1 spray of placebo to each nostril at 5 and 10 minutes) on Days 8 and 11 of Period 2 in Panel A. | None | None | 0 | 8 | 4 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| General Physical Health Deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Ectopic Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 18.0 | View |
| Completed Suicide | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Confusional State | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hangover | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Injection Site Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Product Taste Abnormal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Sluggishness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.0 | View |
| Scratch | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.0 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.0 | View |
| Blood Pressure Diastolic Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 18.0 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 18.0 | View |
| Blood Pressure Systolic Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 18.0 | View |
| Oxygen Saturation Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 18.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Limb Discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Muscle Tightness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Akathisia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Altered State of Consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Coordination Abnormal | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Disturbance in Attention | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Dizziness Postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Dysaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Dysgraphia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Hypersomnia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Loss of Consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Mental Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Psychomotor Hyperactivity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Sedation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Slow Speech | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Tunnel Vision | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Visual Field Defect | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Confusional State | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Daydreaming | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Dissociation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Dissociative Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Hallucination, Visual | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Illusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Merycism | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Somatic Hallucination | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Suspiciousness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Thinking Abnormal | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Bladder Pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 18.0 | View |
| Micturition Urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 18.0 | View |
| Polyuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 18.0 | View |
| Dry Throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Hyperventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Nasal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Nasal Dryness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Nasal Mucosal Disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Nasal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Nasal Oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Nasal Pruritus | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Pharyngeal Disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Pharyngeal Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Throat Irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Upper-Airway Cough Syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | View |
| Dermatitis Contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Scab | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | View |
| Hot Flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 18.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 18.0 | View |
| Peripheral Coldness | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 18.0 | View |
| Sinus Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.0 | View |
| Conjunctivitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.0 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Erosive Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Oesophageal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.0 | View |
| Arthropod Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.0 | View |
| C-Reactive Protein Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 18.0 | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Sensory Disturbance | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.0 | View |
| Depersonalisation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Persecutory Delusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Hypoaesthesia Oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Oral Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Paraesthesia Oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Salivary Hypersecretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Energy Increased | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Feeling Abnormal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Feeling Drunk | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Feeling Hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Feeling Jittery | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Gait Disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |
| Dysphoria | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Fear | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 18.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.0 | View |
| Sinus Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.0 | View |
| Ear Congestion | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 18.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 18.0 | View |
| Accommodation Disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.0 | View |
| Conjunctival Hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.0 | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.0 | View |
| Visual Impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.0 | View |