Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial
Table 4
List adverse events.
Group AE
Code*
Number
Grade**number
Relation
Duration
Outcome
Helixor A
Adverse events
Localized skin reaction at the injection site
10022096
42
Mild Moderate Severe
1 13 27
Definite
Median 4 days (lq 2–uq 6,5)
Resolved without sequelae
Conjunctivitis
10010741
1
Moderate
1
Probable
Unknown
Unknown
Febrile temperature
10021113
1
Severe
1
Unrelated
2 days
Resolved without sequelae
Sting
—
1
Severe
1
Unrelated
Unknown
Unknown
Control
Adverse events
Urticaria (localized)
10046749
1
Mild
1
Unrelated
3 days
Resolved without sequelae
Wound infection
10048038
1
Severe
1
Unrelated
6 days
Resolved without sequelae
Nausea/emesis
10028813
3
Severe
3
Unrelated
2 days
Resolved without sequelae
Control
Serious adverse events:
Nausea/emesis***
10028813
1
Severe
1
Unrelated
4 days
Resolved without sequelae
*Code according to the Medical Dictionary for Regulatory Activities.
**Grading according to the Common Terminology Criteria of Adverse Events (v3.0).
***Patient was hospitalized to treat dehydration. According to the ICH 2A Guidelines hospitalization is defined as “serious adverse event”. Abbreviations: lq: lower quartile; uq: upper quartile; ICH: International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.
