Group | Participant number | Adverse event | Severity | Treatment | Causal relation with the study substance | Reason for causal conclusion | Continuation or discontinuation of the trial |
(symptom) | |||||||
Active | 1 | Fever, Pharyngeal pain | Moderate | Yes | Not related | Occasional event due to an infectious disease and was probably not associated with the study substance. | continued |
Active | 1 | Gastroenteritis | Mild | No | Not related | The participant’s symptoms improved even while continuing to ingest the study substance. The study substance was deemed to be unrelated to the symptoms. | continued |
2 | Cough | Moderate | Yes | Not related | Occasional event due to an infectious disease and was probably not associated with the study substance. | continued | |
3 | Acute otitis media | Moderate | Yes | Not related | Occasional event and was probably not associated with the study substance. | continued | |
Active | 1 | Common cold | Moderate | Yes | Not related | Occasional event due to an infectious disease and was probably not associated with the study substance. | continued |
Active | 1 | Treatment of pus from gums | Moderate | Yes | Not related | Occasional event and was probably not associated with the study substance. | continued |
Active | 1 | Increase of TG, Increase of body weight | Mild | No | Not related | The participant’s triglyceride level was believed to be temporarily elevated because of diet. This was determined to be unrelated to the study substance. | continued |
Placebo | 1 | Pollinosis | Moderate | Yes | Not related | Occasional event and was probably not associated with the study substance. | continued |
Placebo | 1 | Pollinosis | Mild | No | Not related | Occasional event and was probably not associated with the study substance. | continued |
Placebo | 1 | Loose bowel movement | Mild | No | Not related | The symptoms occurred after conclusion of ingesting the study substance. It was concluded that the study substance was unrelated to the symptoms. | continued |
2 | Loose bowel movement | Mild | No | Not related | The symptoms occurred even after the conclusion of ingesting the study substance It was concluded that the study substance was unrelated to the symptoms. | continued | |
Placebo | 1 | Bleeding piles | Moderate | Yes | Not related | Occasional event and was probably not associated with the study substance. | continued |