NCT02718417 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Baseline up to maximum duration of 36 months
- Other-event reporting threshold
- 5%
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Chemotherapy Followed by Avelumab | 92 / 328 | 320 / 328 | 34 / 328 |
| Chemotherapy + Avelumab Followed by Avelumab | 118 / 329 | 325 / 329 | 31 / 329 |
| Chemotherapy Followed by Observation | 64 / 334 | 317 / 334 | 20 / 334 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal abscess
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 334
- term
- Abdominal distension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal hernia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 334
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal pain lower
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal pain upper
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal wall abscess
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Acute kidney injury
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MMedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Adrenal insufficiency
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 334
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Anal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Anaphylactic shock
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 18
- num At Risk
- 334
- term
- Abdominal distension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 69
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 68
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 58
- num At Risk
- 334
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 24
- num At Risk
- 334
- term
- Abdominal pain upper
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 28
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 33
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 334
- term
- Alanine aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 167
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 169
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 177
- num At Risk
- 334
- term
- Alopecia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 148
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 151
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 140
- num At Risk
- 334
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 15
- num At Risk
- 334
- term
- Anxiety
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 76
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 85
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 57
- num At Risk
- 334
- term
- Arthralgia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 334
- term
- Aspartate aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 35
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 46
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 334
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 36
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 31
- num At Risk
- 334
- term
- Back pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 113
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 100
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 95
- num At Risk
- 334
- term
- Constipation
Complete source fields
- description
- Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
- event Groups
- deaths Num Affected
- 34
- deaths Num At Risk
- 328
- description
- In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\*min/mL) x (glomerular filtration rate\[GFR\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
- id
- EG000
- other Num Affected
- 320
- other Num At Risk
- 328
- serious Num Affected
- 92
- serious Num At Risk
- 328
- title
- Chemotherapy Followed by Avelumab
- deaths Num Affected
- 31
- deaths Num At Risk
- 329
- description
- In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \[milligrams\](mg) = Target AUC (mg\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
- id
- EG001
- other Num Affected
- 325
- other Num At Risk
- 329
- serious Num Affected
- 118
- serious Num At Risk
- 329
- title
- Chemotherapy + Avelumab Followed by Avelumab
- deaths Num Affected
- 20
- deaths Num At Risk
- 334
- description
- In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \[milligrams\](mg) = Target AUC \[milligrams\*minute per milliliter\] (mg\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
- id
- EG002
- other Num Affected
- 317
- other Num At Risk
- 334
- serious Num Affected
- 64
- serious Num At Risk
- 334
- title
- Chemotherapy Followed by Observation
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 18
- num At Risk
- 334
- term
- Abdominal distension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 69
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 68
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 58
- num At Risk
- 334
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 24
- num At Risk
- 334
- term
- Abdominal pain upper
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 28
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 33
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 20
- num At Risk
- 334
- term
- Alanine aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 167
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 169
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 177
- num At Risk
- 334
- term
- Alopecia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 148
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 151
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 140
- num At Risk
- 334
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Psychiatric disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 15
- num At Risk
- 334
- term
- Anxiety
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 76
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 85
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 57
- num At Risk
- 334
- term
- Arthralgia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 334
- term
- Aspartate aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 35
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 46
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 334
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 31
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 36
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 31
- num At Risk
- 334
- term
- Back pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 113
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 100
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 95
- num At Risk
- 334
- term
- Constipation
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal abscess
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 334
- term
- Abdominal distension
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal hernia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 334
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal pain lower
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal pain upper
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Abdominal wall abscess
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Acute kidney injury
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Endocrine disorders
- source Vocabulary
- MMedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Adrenal insufficiency
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 334
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Anal haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Immune system disorders
- source Vocabulary
- MedDRA v22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 328
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 329
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 334
- term
- Anaphylactic shock
- time Frame
- Baseline up to maximum duration of 36 months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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