NCT01969838 · 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
- Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.
- Other-event reporting threshold
- 5%
The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Momelotinib (MMB) | 49 / 214 | 197 / 214 | 8 / 214 |
| Ruxolitinib (RUX) | 39 / 216 | 206 / 216 | 6 / 216 |
| MMB to MMB | 79 / 171 | 153 / 171 | 44 / 171 |
| RUX to MMB | 79 / 197 | 188 / 197 | 54 / 197 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 197
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Haemolytic anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 197
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Microangiopathic haemolytic anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 197
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 197
- term
- Splenic haematoma
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Splenic infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Splenic thrombosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 197
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Thrombocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 197
- term
- Acute myocardial infarction
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 24
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 26
- num At Risk
- 197
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 11
- num At Risk
- 197
- term
- Alanine aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 79
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 38
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 29
- num At Risk
- 197
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 13
- num At Risk
- 197
- term
- Arthralgia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 197
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 197
- term
- Back pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 197
- term
- Blood creatinine increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 197
- term
- Bone pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 18
- num At Risk
- 197
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 197
- term
- Contusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 23
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 34
- num At Risk
- 197
- term
- Cough
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 15
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 15
- num At Risk
- 197
- term
- Decreased appetite
Complete source fields
- description
- The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.
- event Groups
- deaths Num Affected
- 8
- deaths Num At Risk
- 214
- description
- Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
- id
- EG000
- other Num Affected
- 197
- other Num At Risk
- 214
- serious Num Affected
- 49
- serious Num At Risk
- 214
- title
- Momelotinib (MMB)
- deaths Num Affected
- 6
- deaths Num At Risk
- 216
- description
- Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
- id
- EG001
- other Num Affected
- 206
- other Num At Risk
- 216
- serious Num Affected
- 39
- serious Num At Risk
- 216
- title
- Ruxolitinib (RUX)
- deaths Num Affected
- 44
- deaths Num At Risk
- 171
- description
- After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
- id
- EG002
- other Num Affected
- 153
- other Num At Risk
- 171
- serious Num Affected
- 79
- serious Num At Risk
- 171
- title
- MMB to MMB
- deaths Num Affected
- 54
- deaths Num At Risk
- 197
- description
- After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
- id
- EG003
- other Num Affected
- 188
- other Num At Risk
- 197
- serious Num Affected
- 79
- serious Num At Risk
- 197
- title
- RUX to MMB
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 24
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 26
- num At Risk
- 197
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 11
- num At Risk
- 197
- term
- Alanine aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 79
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 38
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 29
- num At Risk
- 197
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 13
- num At Risk
- 197
- term
- Arthralgia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 197
- term
- Asthenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 19
- num At Risk
- 197
- term
- Back pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 10
- num At Risk
- 197
- term
- Blood creatinine increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 12
- num At Risk
- 197
- term
- Bone pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 21
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 18
- num At Risk
- 197
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 5
- num At Risk
- 197
- term
- Contusion
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 17
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 23
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 34
- num At Risk
- 197
- term
- Cough
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 15
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 15
- num At Risk
- 197
- term
- Decreased appetite
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 197
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Haemolytic anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 197
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Microangiopathic haemolytic anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 197
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 197
- term
- Splenic haematoma
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Splenic infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Splenic thrombosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 197
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 197
- term
- Thrombocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA (22.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 214
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 216
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 171
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 197
- term
- Acute myocardial infarction
- time Frame
- Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.
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Preserved source evidence · Not medical advice
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