NCT02299089 · 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
- Not reported
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| CAM2029 10 mg q2w (Acromegaly) | 0 / 3 | 2 / 3 | Not reported / Not reported |
| CAM2029 20 mg q4w (Acormegaly) | 0 / 4 | 4 / 4 | Not reported / Not reported |
| CAM2029 10 mg q2w (NET) | 0 / 1 | 0 / 1 | Not reported / Not reported |
| CAM2029 20 mg q4w (NET) | 1 / 4 | 2 / 4 | Not reported / Not reported |
| Sandostatin LAR (Acromegaly) | 0 / 7 | 4 / 7 | Not reported / Not reported |
| Sandostatin LAR (NET) | 0 / 5 | 2 / 5 | Not reported / Not reported |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- notes
- D39, patient noticed intermittent episodes of blood in stools due to a ulceration of a previous anastomosis. Patient received the last injection dose D57 and was hospitalized for investigations of bleeding, resolved on D60, not related to treatment.
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRAversion 16.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Anastomotic ulcer hemorrhage
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- num Events
- 1
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Vertigo
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Eyelid disorder
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Food poisoning
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Diabetes Mellitus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Cough
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Erythema
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Diverticulum Intestinal
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Haematochezia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Hiatus hernia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Large intestine polyp
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Nausea
Complete source fields
- event Groups
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot Day 0-84
- id
- EG000
- other Num Affected
- 2
- other Num At Risk
- 3
- serious Num Affected
- 0
- serious Num At Risk
- 3
- title
- CAM2029 10 mg q2w (Acromegaly)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot Day 0-84
- id
- EG001
- other Num Affected
- 4
- other Num At Risk
- 4
- serious Num Affected
- 0
- serious Num At Risk
- 4
- title
- CAM2029 20 mg q4w (Acormegaly)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot Day 0-84
- id
- EG002
- other Num Affected
- 0
- other Num At Risk
- 1
- serious Num Affected
- 0
- serious Num At Risk
- 1
- title
- CAM2029 10 mg q2w (NET)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot Day 0-84
- id
- EG003
- other Num Affected
- 2
- other Num At Risk
- 4
- serious Num Affected
- 1
- serious Num At Risk
- 4
- title
- CAM2029 20 mg q4w (NET)
- description
- Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups
- id
- EG004
- other Num Affected
- 4
- other Num At Risk
- 7
- serious Num Affected
- 0
- serious Num At Risk
- 7
- title
- Sandostatin LAR (Acromegaly)
- description
- Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups
- id
- EG005
- other Num Affected
- 2
- other Num At Risk
- 5
- serious Num Affected
- 0
- serious Num At Risk
- 5
- title
- Sandostatin LAR (NET)
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 5
- num Events
- 1
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Vertigo
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Eyelid disorder
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Food poisoning
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Diabetes Mellitus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Cough
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Erythema
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Diverticulum Intestinal
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Haematochezia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Hiatus hernia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Large intestine polyp
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (16.0)
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Nausea
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- notes
- D39, patient noticed intermittent episodes of blood in stools due to a ulceration of a previous anastomosis. Patient received the last injection dose D57 and was hospitalized for investigations of bleeding, resolved on D60, not related to treatment.
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRAversion 16.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 4
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 1
- num Events
- 0
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 4
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 7
- num Events
- 0
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 5
- num Events
- 0
- term
- Anastomotic ulcer hemorrhage
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Preserved source evidence · Not medical advice
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