NCT04731844 · 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
- 1 year
- Other-event reporting threshold
- 0%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Prostate Cancer | 1 / 12 | 10 / 12 | 0 / 12 |
| Smoldering Multiple Myeloma (SMM) | 0 / 8 | 7 / 8 | 0 / 8 |
| Monoclonal Gammopathy of Unknown Significance (MGUS) | 0 / 9 | 8 / 9 | 0 / 9 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Esophageal perforation
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 9
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Alanine Aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- term
- Back Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 9
- term
- constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Creatinine Increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Right lower extremity edema
- organ System
- General disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Edema Limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Thyroid mass of unclear etiology, Goiter
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Endocrine Disorders-Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Diplopia
- organ System
- Eye disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Eye Disorders-Other, specify
Complete source fields
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 12
- description
- Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
- id
- EG000
- other Num Affected
- 10
- other Num At Risk
- 12
- serious Num Affected
- 1
- serious Num At Risk
- 12
- title
- Prostate Cancer
- deaths Num Affected
- 0
- deaths Num At Risk
- 8
- description
- Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
- id
- EG001
- other Num Affected
- 7
- other Num At Risk
- 8
- serious Num Affected
- 0
- serious Num At Risk
- 8
- title
- Smoldering Multiple Myeloma (SMM)
- deaths Num Affected
- 0
- deaths Num At Risk
- 9
- description
- Curcumin plus Piperine at a dose of 2gm/10mg orally BID for 12 months Curcumin plus Piperine: Curcumin with piperine is a well-tolerated over-the-counter supplement.
- id
- EG002
- other Num Affected
- 8
- other Num At Risk
- 9
- serious Num Affected
- 0
- serious Num At Risk
- 9
- title
- Monoclonal Gammopathy of Unknown Significance (MGUS)
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 9
- term
- Abdominal Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Alanine Aminotransferase increased
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 9
- term
- Back Pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 9
- term
- constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Creatinine Increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- dyspnea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Right lower extremity edema
- organ System
- General disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Edema Limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Thyroid mass of unclear etiology, Goiter
- organ System
- Endocrine disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Endocrine Disorders-Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- notes
- Diplopia
- organ System
- Eye disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- term
- Eye Disorders-Other, specify
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 5.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 12
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 8
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 9
- num Events
- 0
- term
- Esophageal perforation
- time Frame
- 1 year
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Preserved source evidence · Not medical advice
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