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Table 5 List of Adverse Reactions

From: Artichoke phytocomplex modulates serum microRNAs in patients exposed to asbestos: a first step of a phase II clinical trial

Adverse Reactions in Analyzable Group (n = 18)

ID

Reg Date

Day

AR Description

AR#

Start

Date

Stop

Date

On-

going

Grade

Action

Outcome

Relation

1

26-Nov-14

85

Fell—skinned knee

1

19-Feb-15

19-Feb-15

 

mild

no change

resolved

unrelated

1

 

88

Fell—sore hip

2

22-Feb-15

22-Feb-15

 

mild

no change

resolved

unrelated

2

26-Nov-14

24

Infection—respiratory

1

20-Dec-14

17-Jan-15

 

moderate

no change

resolved

unrelated

2

 

28

Diarrhea

2

24-Dec-14

27-Dec-14

 

mild

no change

resolved

unrelated

2

 

68

Decreased appetite

3

02-Feb-15

 

Yes

moderate

no change

chronic

doubtful

3

06-Jan-15

40

Infection—respiratory

1

15-Feb-15

01-Mar-15

 

moderate

no change

resolved

unrelated

8

09-Feb-15

86

Insect bite

1

06-May-15

 

Yes

mild

no change

chronic

unrelated

10

09-Mar-15

50

Phlegm

1

28-Apr-15

 

Yes

mild

no change

chronic

unrelated

14

27-Mar-15

61

Hand Injury

1

27-May-15

23-Jun-15

 

moderate

no change

resolved

unrelated

14

 

61

Diarrhea

2

27-May-15

01-Jul-15

 

mild

no change

chronic

unrelated

16

13-Apr-15

16

Hypertension—unstable

1

29-Apr-15

 

Yes

moderate

no change

chronic

unrelated

21

20-Jul-15

7

Constipation

1

27-Jul-15

03-Aug-15

 

mild

no change

resolved

unrelated

Adverse Reactions in 3 Patients Who Took Study Drug and Then Withdrew

ID

RegDate

Day

AR Description

AR#

Start

Date

Stop

Date

On-

going

Grade

Action

Outcome

Relation

5

08-Jan-15

0

Lightheaded

1

08-Jan-15

13-Jan-15

 

mild

Perm Disc

resolved

probable

19

01-Jun-15

3

Diarrhea

1

04-Jun-15

22-Jun-15

 

mild

Perm Disc

resolved

probable

20

02-Jul-15

30

Diarrhea

1

01-Aug-15

09-Aug-15

 

severe

no change

resolved

possible

20

 

30

Pain—Back

2

01-Aug-15

 

Yes

moderate

no change

chronic

unrelated

20

 

50

Diarrhea

3

21-Aug-15

30-Aug-15

 

severe

Perm Disc

resolved

probable